Effects of Hemoadsorption on Vascular Integrity in Septic Shock (NCT07711197) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effects of Hemoadsorption on Vascular Integrity in Septic Shock
Hungary110 participantsStarted 2026-09-01
Plain-language summary
This study aims to investigate the effects of adjunctive CytoSorb hemoadsorption therapy versus standard medical treatment on endothelial dysfunction in patients with refractory septic shock. The investigators hypothesize that hemoadsorption mitigates endothelial and glycocalyx injury by removing inflammatory mediators and other injurious circulating molecules, promoting hemodynamic stabilization.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Septic shock as defined by Sepsis-3 criteria.
* Serum lactate levels \>2 and \<8 mmol/L at screening.
* Fluid unresponsiveness: Objectively confirmed via dynamic tests or fluid challenges following initial resuscitation.
* Vasopressor Dose Threshold: Norepinephrine base equivalent (NEE) dose \> 0.5 µg/kg/min.
* Systemic corticosteroid treatment on board for at least 30 minutes.
* Tissue perfusion impairment: Persistently elevated serum lactate AND/OR prolonged capillary refill time (\> 3 seconds) despite standard therapy.
* Alternative causes of shock (e.g., obstructive or cardiogenic) must be ruled out using critical care ultrasonography (CCUS).
* Arterial, central venous catheters and an invasive hemodynamic device (PiCCO, Getinge) in place.
* Inclusion within a maximum of 12 hours after the onset of vasopressor need.
* High likelihood of a dysregulated immune response (PCT ≥ 5 ng/mL AND/OR IL-6 ≥ 1000 pg/mL AND/OR Ferritin ≥ 1000 ng/mL).
* Written informed, retrospective or prospective consent.
Exclusion Criteria:
* Patients under 18 years of age and over 80.
* Unlikely to survive for 24 hours (Moribund).
* Pregnancy.
* SOFA-2 score ≥ 16 at ICU admission.
* Source control is uncertain.
* Thrombocytopenia (\<20,000/µL).
* Criteria of standard guideline-based medical treatment not exhausted.
* End-stage organ failure (chronic renal failure (estimated glomerular filtration rate (eGFR) \<15 mL/min/1.73 m2), chronic liver failure (MELD Score \>30, Child…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in Syndecan-1 serum levels
Timeframe: Baseline (T0), 6, 12, 18, and 24 hours, and then daily up to 5 days (including pre- and postadsorbent samples in the CytoSorb group)